UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061261 |
|---|---|
| Receipt number | R000070093 |
| Scientific Title | Analysis of background factors and hemodynamics in pipeline esophageal varices and database construction |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 20:02:26 |
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Basic information
Public title
Analysis of background factors and hemodynamics in pipeline esophageal varices and database construction
Acronym
PEV-Study (Pipeline Esophageal Varices Study)
Scientific Title
Analysis of background factors and hemodynamics in pipeline esophageal varices and database construction
Scientific Title:Acronym
PEV-Study (Pipeline Esophageal Varices Study)
Region
| Japan |
Condition
Condition
Pipeline esophageal varices
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter retrospective cohort study aims to clarify the clinical characteristics and hemodynamic features of pipeline esophageal varices, a rare subtype of esophageal varices. Clinical data, including patient background, hemodynamic findings, and treatment modalities, will be collected and analyzed from multiple institutions. In addition, a database will be established based on these data to generate findings that may contribute to the development of appropriate management strategies for pipeline esophageal varices.
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical characteristics of patients with pipeline esophageal varices.
To assess the hemodynamic features of pipeline esophageal varices.
To investigate treatment modalities for pipeline esophageal varices.
To analyze overall survival in patients with pipeline esophageal varices.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic findings at the time of diagnosis of pipeline esophageal varices
(assessed by contrast-enhanced CT and/or EVIS images, including the maximum short diameter of the esophageal varix, type of feeding vessel [left gastric vein, posterior gastric vein, or short gastric vein], maximum short diameter of the feeding vessel, maximum short diameter of the splenic vein, and presence of portosystemic shunts)
Key secondary outcomes
1. Patient background characteristics and clinical findings at the time of diagnosis of pipeline esophageal varices
(age, sex, BMI, alcohol history, smoking history, previous treatment for esophageal varices, history of HCC treatment, and survival status)
2. Laboratory findings at the time of diagnosis of pipeline esophageal varices
(white blood cell count, hemoglobin, platelet count, total protein, albumin, AST, ALT, ALP, gamma-GTP, BUN, creatinine, PT, PT-INR, D-dimer, FDP, AT-III, ammonia, antinuclear antibody, antimitochondrial antibody, antimitochondrial M2 antibody, hyaluronic acid, type IV collagen 4S, and M2BPGi)
3. Endoscopic findings at the time of diagnosis of pipeline esophageal varices
(location, presence of gastric varices, continuity/communication with esophageal varices, form, and presence of red color signs)
4. Treatment modalities for pipeline esophageal varices
(endoscopic treatment, medical treatment, IVR, and surgical treatment)
5. Overall survival
(from the date of diagnosis of pipeline esophageal varices to the date of last confirmed survival or death)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with pipeline esophageal varices at participating institutions between January 1, 2000 and October 31, 2025
For the control group, patients who underwent endoscopic treatment for conventional esophageal varices at Yamagata University Hospital during the same period
No age restriction
Key exclusion criteria
Patients who declined participation via the opt-out procedure
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Haga |
Organization
Yamagata University
Division name
Department of Gastroenterology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata
TEL
023-628-5309
hihaga@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Maki |
Organization
Yamagata University
Division name
Department of Gastroenterology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata
TEL
023-628-5309
Homepage URL
k-maki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Hiroaki Haga
Funding Source
Organization
Yamagata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University
Address
2-2-2 Iida-nishi, Yamagata
Tel
023-628-5309
hihaga@med.id.yamagata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
山形県
Institutions
Institutions
山形大学医学部附属病院（山形県）、獨協医科大学病院（栃木県）、福島県立医科大学附属病院（福島県）、東北大学病院（宮城県）、弘前大学医学部附属病院（青森県）、秋田大学医学部附属病院（秋田県）、岩手医科大学附属病院（岩手県）、山形県立新庄病院（山形県）、総合南東北病院（福島県）、福島県立医科大学会津医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter retrospective observational study, and no additional intervention will be performed as part of the study. To clarify the clinical characteristics and hemodynamic features of pipeline esophageal varices, which is a rare condition, cases will be collected and analyzed from multiple institutions. Conventional esophageal varices cases at Yamagata University Hospital will be used as the control group. Informed consent will be obtained using an opt-out procedure.
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070093
